Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism

Not Applicable

Withdrawn

• Conditions: Non Obstructive Azoospermia; Hypogonadism
• Interventions: Drug: Placebo; Drug: Clomiphene

• Registration Number: NCT02137265
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

Detailed Description

Hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. However, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microTESE improve.

Study Timeline

• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-13
• Study Start: 2015-09
• Status Verified: 2020-10
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Patients over 18 years old.
• Man seeking fertility treatment.
• Azoospermia confirmed in at least 2 semen analyses with centrifugation.
• Testosterone <300 ng/dL and Bioavailable Testosterone<156 ng/dL.

Exclusion Criteria

• Presence of genetic disorders: Y chromosome deletions or abnormal karyotypes.
• Luteinizing hormone (LH) >25 IU/mL.
• Estradiol > 40 ng/dL.
• Hypogonadotropic hypogonadism (LH <2 IU/mL and Follicle Stimulating Hormone (FSH) <1 IU/mL).
• Obstructive azoospermia (FSH <7.6 IU/mL plus testicle longitudinally axis >4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy).
• Clinical varicocele (palpable or visible in physical exam)
• Previous history of cryptorchidism.
• Use of chemotherapy, testosterone, or anti-androgen in the last two years. Partner >40 years or female factor infertility associated.
• Contraindications to clomiphene use: depression, heart and liver impairment, uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (1 pill daily) during 4-6 months
Clomiphene citrate	Clomiphene	Clomiphene citrate 50 mg daily during 4-6 months

Primary Outcome Measures

Name	Time	Method
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)	After four months of clomiphene treatment
Epigenetic modifications	After four months of clomiphene treatment

Secondary Outcome Measures

Name	Time	Method
Testosterone levels and Bioavailable Testosterone levels	After two weeks and four months with clomiphene treatment

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Province Of Valencia, Spain